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Wednesday, June 10, 2020

Nasdaq closes above 10,000 milestone, even as economy is in recession

The Nasdaq Composite Index closed at an important milestone for the first time on Wednesday, underscoring the rebound in technology-related stocks following the coronavirus rout that has helped to crystallize the view that parts of the stock market have entered a new bullish phase.
The rally for the tech-laden index comes after a series of fresh record closing highs for the index. A finish at or above 10,000 represents the fastest 1,000-point milestone for the Nasdaq COMP, +0.66%, 114 trading sessions, since the 49 sessions the index took to surge from 4,000 to 5,000 in 2000, according to data from Dow Jones Market Data.
The U.S. stock market, hit by an economy falling into recession as businesses were temporarily closed to combat the coronavirus pandemic, has staged a rapid rebound from its low in late March. The Nasdaq and its peer index, the Nasdaq-100, composed of the largest members of the Nasdaq Composite, is weighted heavily with technology businesses which have been viewed as more resilient to the COVID-19 pandemic that has rocked the economy and financial markets.
Check out a table of the milestones in the attached table:
The largest names by market value have helped to propel the recovery for the Nasdaq. Those companies include Facebook Inc. FB, -0.81%, Apple Inc. AAPL, +2.57%, Amazon.com Inc. AMZN, +1.79%, Netflix NFLX, +0.09% and Google parent Alphabet GOOG, +0.66% GOOGL, +0.86%.
To be sure, round numbers like 10,000 on the index aren’t necessarily significant for the market, but they can help to reflect growing upbeat sentiment, despite a number of risks that have confronted investors including the viral epidemic and civil unrest that erupted over the death of unarmed black man George Floyd in Minneapolis.
The Nasdaq closed on Wednesday at 10,020.35.
The Dow, which was first published 124-years ago, hit 10,000 in March 29, of 1999 as the tech sector was in the throws of the dot-com boom. The Nasdaq Composite, meanwhile, was first published in 1971, so its traverse above the 10,000 mark comes at a relatively brisk half-century clip.
Wednesday’s trading for the Nasdaq comes as the Federal Reserve said that it would do whatever its takes to support the economy and financial markets. Still, there are growing concerns that the rebound from the rout induced by COVID-19 has come too fast and too furiously, making the equity market more vulnerable to a sharp pullback.
The Dow Jones Industrial Average DJIA, -1.03% closed off 1% Wednesday, ending lower after it snapped a six-session rally on Tuesday, while the S&P 500 SPX, -0.53% finished off 0.5%.
Indeed, the economy has tumbled into such a deep recession that some forecasters predict up to a record 40% decline in gross domestic product on an annualized basis in the second quarter. In the first quarter, the economy contracted by 4.8%, one of the deepest declines on record.
The Fed on Wednesday said it doesn’t expect to lift short-term rates through the end of 2022. In a statement, the Fed said again it would use its “full range of tools” to support the economy.
https://www.marketwatch.com/story/nasdaq-on-the-verge-of-closing-at-psychological-milestone-at-10000-even-as-the-economy-is-in-recessionheres-how-we-got-here-2020-06-09

Expanded use of Vertex’s Kalydeco OK’d in Europe

The European Commission approves the use of Vertex Pharmaceuticals’ (NASDAQ:VRTX) Kalydeco (ivacaftor) in children with cystic fibrosis as young as six months old and weighing at least 5 kg who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
The product was previously approved for CF sufferers ages 18 and older with the R117H mutation, and in infants ages six months and older weighing at least 5 kg who have one of the following mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
https://seekingalpha.com/news/3581804-expanded-use-of-vertexs-kalydeco-okd-in-europe

FDA OKs expanded emergency use of Quidel COVID-19 test

The FDA has amended its Emergency Use Authorization for Quidel’s (OTC:QDEL) rapid point-of-care Sofia SARS Antigen FIA test to allow it to be run on its automated Sofia Fluorescent Immunoassay Analyzer that can generate results in as little as 15 minutes.
https://seekingalpha.com/news/3581808-fda-oks-expanded-emergency-use-of-quidel-covidminus-19-test

FDA OKs emergency use of Illumina’s COVID-19 diagnostic test

The FDA has issued an Emergency Use Authorization for Illumina’s (NASDAQ:ILMN) COVIDSeq Test, a sequencing-based, in vitro diagnostic workflow enabling the detection of SARS-CoV-2.
The end-to-end workflow extends the options available for labs to scale diagnostic testing.
COVIDSeq uses upper respiratory specimens and delivers sample receipt to result in 24 hours using the NovaSeq 6000 Sequencing System.
The test currently has limited availability and is expected to be more broadly available this summer.

Fulcrum Therapeutics to test losmapimod in COVID-19

Fulcrum Therapeutics (NASDAQ:FULC) has filed an IND with the FDA seeking sign-off for a late-stage clinical study evaluating lead drug losmapimod in hospitalized COVID-19 patients.
According to President & CEO Robert Gould, Ph.D., prior studies in other diseases showed the drug’s ability to reduce inflammatory proteins like IL-6 and C-reactive protein (CRP) that are associated with a poor prognosis.
On the working capital front, it has closed its $68.5M private placement of stock (~4M common shares at $17). Its current balance of quick assets should be sufficient to fund operations into Q1 2022.
Management hosted a conference call today at 8:30 am ET to discuss recent developments.
https://seekingalpha.com/news/3581828-fulcrum-therapeutics-to-test-losmapimod-in-covidminus-19

RedHill files for study of opaganib in COVID-19

RedHill Biopharma Ltd. (NASDAQ:RDHL) has filed an application with the Ministry of Health in Russia seeking sign-off for a Phase 2/3 clinical trial evaluating Yeliva (opaganib) in severely ill hospitalized COVID-19 patients.
The randomized, double-blind, parallel-arm, placebo-controlled study will enroll 270 subjects with severe COVID-19 pneumonia who are receiving supplemental oxygen. They will be randomized 1:1 to receive either opaganib or placebo on top of standard-of-care treatment.
The primary endpoint will be the proportion of patients requiring mechanical ventilation by day 14. Preliminary data should be available when ~100 participants have been evaluated for the primary objective.
The trial will include sites across Europe in addition to Russia and other countries.
Opaganib inhibits an enzyme called sphingosine kinase-2 (SK2) which blocks the synthesis of a lipid-signaling molecule called sphingosine 1-phosphate (S1P) that promotes cancer cell growth and pathological inflammation.
https://seekingalpha.com/news/3581843-redhill-files-for-study-of-opaganib-in-covidminus-19

Biogen’s Spinraza shows sustained benefit in presymptomatic SMA patients

Biogen (NASDAQ:BIIB) announces new positive data from its long-term NURTURE study evaluating Spinraza (nusinersen) in presymptomatic patients with spinal muscular atrophy (SMA).
At data cutoff in February which includes almost an additional year of follow-up, all treated patients (n=25; median age: 3.8 years) were alive and remained permanent ventilation-free. All children who have been able to walk independently have maintained their ability to do so.
No new safety signals have been reported.
The open-label study has been extended for another three years.
Related ticker: Ionis Pharmaceuticals (NASDAQ:IONS)

https://seekingalpha.com/news/3581849-biogens-spinraza-shows-sustained-benefit-in-presymptomatic-sma-patients